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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Roxy Trading Inc 3/24/10

 

 

 

   

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
  Los Angeles District
Pacific Region
19701 Fairchild
Irvine, CA 92612-2506
Telephone: 949-608-2900
FAX: 949-608-4415

WARNING LETTER

 

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

W/L 11-10

 

March 24, 2010

 

Mr. Sieng U. Saetang, President/Owner
Roxy Trading Inc.
389 Humane Way.
Pomona, CA 91768

Dear Mr. Saetang:

The Food and Drug Administration (FDA) detained your product, Sweet Plait Biscuits which was offered for import into the United States. On July 22, 2008, your company, Roxy Trading, located at 1388 W. Foothill Blvd, Azusa, CA 91702 offered for import into the United States various food articles including (b)(4) cartons of Sweet Plait Biscuits under entry number 8800070467-1. This entry was sampled by the Food and Drug Administration (FDA) on August 21, 2008 and found to be adulterated with Rhodamine B (formerly known as D&C Red 19), a suspected carcinogen and non-permitted color additive for food. The product was initially detained and subsequently refused by FDA on December 1, 2008 pursuant to Sections 402 (c) [21 U.S.C. § 342], 801(a)(3) [21 U.S.C. § 381] and 721 (a) [21 U.S.C. §379e] of the Federal Food, Drug, and Cosmetic Act (the Act).

On December 11, 2008 the refused Sweet Plait Biscuits were stamped as "REFUSED Dec 11, 2008 FDA LOS-DO" and processed for exportation. Per Bill of Lading No. 08-0848, dated December 18, 2008, the articles were on board to the consignee, (b)(4)

On April 2, 2009, entry number 880-0073743-2, consisting of various products including (b)(4) of Sweet Plait Biscuits was sampled by FDA. These samples disclosed the presence of Rhodamine B in this entry. The product was refused entry on June 22, 2009 due to the non-permitted food color pursuant to Section 402 (c) [21 U.S.C. § 342], Section 721 (a) [21 U.S.C. § 379e], and Section 801 (a)(3) [21 U.S.C. § 381] of the Act.

On October 21, 2009, an FDA inspection was conducted to verify that all of the (b)(4) of "FDA Refused" Sweet Plain Biscuits for entry number 880-0073538-6 were held intact by the Importer. A total of  (b)(4) were presented to the FDA investigator. (b)(4) were stamped as "REFUSED Dec 11, 2008, (b)(4) appeared to be deliberately manipulated, with areas of the master carton packaging missing. The missing sections of the master cartons appear to be the size of the FDA "REFUSED" stamp. The shipper for this entry was (b)(4) which was the same consignee for entry number 880-0073743"2 which was witnessed by FDA to have been exported on December 11, 2008. Based on the above findings we have concluded that your company re-imported into the United States adulterated products that were initially refused entry by FDA.

As the importer of record, it is your responsibility to ensure that all imported products meet all requirements of the Federal Food Drug and Cosmetic Act and the regulations promulgated thereunder. These responsibilities include but are not limited to introduction and distribution of products in US commerce which are not adulterated and do not contain an FDA refusal stamp that demonstrates that the products were previously examined and refused entry by FDA. Your film also has an ongoing responsibility to ensure that all shippers, import brokers, consignees and others working on your behalf follow all requirements of the Act and the regulations promulgated thereunder.

We remind you that introduction into or receipt in interstate commerce of any article that is adulterated or misbranded is a violation of the Act and may result in regulatory action without further notice such as seizure, detention without physical examination of shipments, debarment, injunction and prosecution. In addition, failure to promptly correct the deviations and prevent distribution of adulterated import products may result in requiring that future shipments be held in secured storage. Secured storage will be under the supervision and direction of the U.S. Customs Border Protection, such as in a bonded warehouse. You will be responsible for all costs incurred in secured storage.

Please respond to this letter within fifteen (15) working days from receipt of this letter, of specific steps you have taken to correct these violations, including an explanation of each step taken to prevent their recurrence and the status of the removal of all adulterated products. Your response should include copies of any available documentation demonstrating that corrections have been made. If corrections cannot be completed within fifteen working days, state the reason for the delay and the time frame within which the corrections will be completed.

Your written reply should be directed to:

U.S. Food & Drug Administration
Attn: Dan Solis
Director, Import Operations Branch
Los Angeles District
222 West 6th Street, Suite 700
San Pedro, CA 90731

 

If you have questions regarding any issue in this letter, you may contact CDR Susanna Choi, Investigator at 310-971-2293. 

 

Sincerely,

/s/


Alonza E. Cruse
District Director
Los Angeles District

 

CC: U.S. Customs and Border Protection
Team 710 Import Specialist Team
301 East Ocean Blvd
Long Beach, CA 90802

 

Department of Health Services
Food and Drug Branch
P.O. Box 997413, MS-7602
Sacramento, CA 95899-7413